A Phase 1, Open-label, Single Arm Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Saroglitazar Magnesium Dosed on Alternate Days in Subjects Having Moderate Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
Zydus Therapeutics Inc.
Summary
Evaluating Pharmacokinetic and safety of Saroglitazar Magnesium 1 mg when dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease
Description
A phase 1, open-label, single arm study to evaluate pharmacokinetics, safety, and tolerability of Saroglitazar Magnesium dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male and/or female aged 18 to 80 years (both inclusive) at the time of signing the ICF. 2. Body mass index within the range 18.0 to 48.0 kg/m2 (inclusive) at screening. 3. Ability to swallow and retain oral medication. 4. Subjects having documented history of hepatic impairment with cirrhosis due to cholestatic liver disease having Child-Pugh Turcotte score 7 to 9. If the hepatic impairment classification for the subject is not the same at screening and Day -1, enrolment of the subject into a hepatic category group will be at the discretion of the investigator. 5. Labor…
Interventions
- DrugSaroglitazar Magnesium 1 mg
Saroglitazar Magnesium 1 mg will be assigned to all participants enrolled in this open label study
Location
- Zydus Site US001Indianapolis, Indiana